EPSOM SALT- magnesium sulfate granule

Epsom Salt by

Drug Labeling and Warnings

Epsom Salt by is a Otc medication manufactured, distributed, or labeled by Freds Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Magnesium sulfate USP 100%

Purpose

 Saline laxative

Uses

• relieves occasional constipation (irregularity)
• generally produces bowel movement in 1/2 to 6 hours

Warnings

Ask a doctor before use if you have

• kidney disease
• a magnesium restricted diet
• stomach pain, nausea or vomiting
• noticed a sudden change in bowel habits that lasts more than 2 weeks

Ask a doctor or pharmacist before use if you are

 presently taking a prescription drug.

When using this product

• do not use more than directed

Stop use and ask a doctor if

• you have rectal bleeding or failure to have a bowel movement after use. This may indicate a serious condition.
• you need to use a laxative for more than 1 week

If pregnancy or breast-feeding,

 ask a health professional before use.

Keep out of reach of children.

 In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• do not exceed more than 2 doses per day; if necessary repeat dosage in 4 hours

• age: dose
• adults and children 12 years and older: 2-4 level teaspoons dissolved in a full glass (8oz) of water
• children 6 to 11 years:

  1-2 level teaspoons in a full glass (8oz) of water

Not recommended for children under 6 years of age.

Inactive Ingredients

None

Other information

• each teaspoon contains: magnesium 495 mg

Questions or comments?

For laxative or soak, call 1-877-753-3935 Monday- Friday 9AM-5PM EST

Principal Display Panel

EPSOM SALTS

Magnesium Sulfate U.S.P.

Soaking Aid

For minor sprains and bruises

Saline Laxative

for relief of occasional constipation

NET WT OZ  (LB)

TAMPER EVIDENT: DO NOT USE IF HEAT SEALED POUCH IS IMPROPERLY SEALED.

DISTRIBUTED BY: fred's Inc.

4300 NEW GETWELL ROAD,

MEMPHIS, TN 38118

www.fredsinc.com

Package Label

FRED'S PHARMACY Epsom Salt

INGREDIENTS AND APPEARANCE

EPSOM SALT 
magnesium sulfate granule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-395
Route of Administration	ORAL, TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM SULFATE, UNSPECIFIED	1 g  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55315-395-01	454 g in 1 POUCH; Type 0: Not a Combination Product	02/28/2018
2	NDC: 55315-395-04	1814 g in 1 POUCH; Type 0: Not a Combination Product	02/28/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	02/28/2018

Labeler - Freds Inc (005866116)